EP2664357A1 - Defibrillationsschockstärkenbestimmungstechnik - Google Patents

Defibrillationsschockstärkenbestimmungstechnik Download PDF

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Publication number
EP2664357A1
EP2664357A1 EP13180020.3A EP13180020A EP2664357A1 EP 2664357 A1 EP2664357 A1 EP 2664357A1 EP 13180020 A EP13180020 A EP 13180020A EP 2664357 A1 EP2664357 A1 EP 2664357A1
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EP
European Patent Office
Prior art keywords
shock
test
wave
strength
shock strength
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Granted
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EP13180020.3A
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English (en)
French (fr)
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EP2664357B1 (de
Inventor
Charles D. Swerdlow
Kalyanam Shivkumar
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3925—Monitoring; Protecting
    • A61N1/3937—Monitoring output parameters
    • A61N1/3943—Monitoring output parameters for threshold determination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3987—Heart defibrillators characterised by the timing or triggering of the shock

Definitions

  • the present invention relates, generally, to implantable cardioverter defibrillators (ICDs) and defibrillation methods, and particularly to a method and apparatus for determining the optimal shock strength for defibrillation, and most particularly to determining the upper limit of vulnerability (ULV) based on changes with respect to time in the T-wave of the cardiac signal, preferably the maximum of the first derivative of the T-wave with respect to time measured preferably exclusively from implanted electrodes.
  • the term "derivative of the T-wave” refers to the first derivative of the T-wave with respect to time.
  • the technology is useful for automating the process of selecting the first defibrillation shock strength for ICDs.
  • One method is to use the maximum shock strength of the ICD for each shock.
  • this approach is an inefficient use of the ICD's limited stored electrical energy and will unnecessarily reduce the useful life of an ICD pulse generator.
  • a goal of clinical testing at ICD implantation is to estimate a shock strength in the range of the DFT 95 - DFT 99 . This is the optimal strength at which to program the first shock of an ICD. For research purposes, it may be preferable to estimate the DFT 50 .
  • DFT methods require additional fibrillation-defibrillation episodes after a defibrillation shock has failed.
  • fibrillation is reinitiated after a failed defibrillation shock and defibrillation is attempted at successively higher shock strengths until a shock defibrillates the heart successfully.
  • This change from a shock strength that does not defibrillate to one that does (or vice versa) is called a reversal of response.
  • DFT methods may require a fixed number of reversals. If the size of the shock increments and decrements is the same, a multiple-reversal (up-down) method provides a good estimate of the DFT 50 .
  • An alternative Bayesian method uses a predetermined number of unequal shock increment steps and decrement steps to estimate an arbitrary, specific point on the DFT probability of success curve.
  • U.S. Patent. 5,346,506 Another method for establishing a ULV is disclosed in U.S. Patent. 5,346,506 .
  • the method relies on research demonstrating that the 50% probability of successful defibrillation can be approximated by determining the 50% probability that a shock exceeds the ULV.
  • a shock is applied to the heart through epicardial patches at a predetermined limited period of time centered on the mid-upslope of the T-wave.
  • the disclosure argues that the total number of shocks is reduced by not having to scan the entire T-wave with shocks.
  • a disadvantage of this method is that the shock strength for the first application must be estimated beforehand. The number of shocks required to determine the DFT is reduced only if the estimated 50% probability of reaching the ULV is quite accurate. Further, this method requires multiple fibrillation-defibrillation episodes, with their attendant risks, to provide an accurate estimate of the shock energy required to achieve a 50% probability of successful defibrillation.
  • the analyzed electrogram may be recorded from large extra-cardiac or intra-cardiac electrodes. Recordings from these large electrodes contain more information regarding global repolarization than recordings from point electrodes.
  • the present invention provides an automatic ICD system and method which is practical, reliable, accurate, and efficient, and which is believed to fulfill the need and to constitute an improvement over the background technology.
  • the system and method quickly and accurately determines the optimal first shock strength of an ICD system for a patient by evaluating the heart's ULV during or after implantation. As noted above, the ULV, if measured correctly, correlates closely with a shock strength that defibrillates with a high probability of success.
  • a local change in a function may indicate whether the function has a local minimum, local maximum, or local saddle point at a value of an independent variable.
  • a local minimum and a local maximum are called extreme points for the function.
  • a local maximum of an ECG function during a T-wave indicates a point at which cardiac-related repolarization changes cause the largest change in a patient's iso-electric potential as it is measured using an ECG device.
  • a local maximum and a local minimum of a derivative of an ECG function during a T-wave can indicate points at which the local changes during the cardiac-related repolarization are changing or varying at the highest rates.
  • the ULV is determined after the electrodes and leads have been placed at their permanent positions. In this manner, the DFT corresponds to the patient and particular arrangement of the defibrillation electrodes used.
  • ULV subsystem 50 an upper limit of vulnerability (ULV) subsystem 50 according to the present invention is depicted in one possible configuration in electrical connection with a shock subsystem 52.
  • ULV subsystem 50 and shock subsystem 52 are component subsystems of ICD 10 of FIG. 1 and are contained within housing 12 and electrically connected.
  • ULV subsystem 50 includes a test-shock driver for T-wave shocks 54, a test/treatment controller 56, a timing circuit 58, a sensing, storing, and analyzing circuit 60, a pacing circuit 62 (in a preferred embodiment), and a memory unit 64.
  • the timing of the pacer spike 90 may be transmitted to the sensing circuit electronically by methods well known in the art.
  • the sensing, storing, and analyzing circuit 60 may identify the pacer spike 90 during its evaluation of the intra-cardiac electrogram.
  • the present invention anticipates an ability to evaluate the ECG or electrogram signals derived from a number of different configurations of implanted electrodes including, but not limited to, intracardiac, epicardial, intravascular, subcutaneous, and submuscular leads.
  • sensing lead combinations may include leads positioned to record signals from the superior vena cava, the right atrium, the right ventricle, the left ventricle and combinations of electrodes such as between a lead tip electrode and a defibrillation electrode or combinations including pairing leads from the right atrium or the superior vena cava to the right or left ventricles.
  • each row corresponds to the last two beats of successive pacing trains (a)-(d).
  • Base time intervals 100a-d may be measured on the next to last beats of the pacing trains (following pacer spikes 90a-d), and test shocks delivered into the T-wave of the last beats of the train (following pacer spikes 90a'-d').
  • the starting shock strength and offset time ⁇ T a-d are stored in memory unit 64 and are chosen according to a predetermined protocol.
  • the starting shock strength is in the range of 5-30 J, preferably between 10-15 J, and most preferably 15 J.
  • Offset time ⁇ T may be positive, negative or zero. Offset time ranges between negative (-) 60 ms and positive (+) 40 ms and is preferably -20 ms to + 40 ms for a standard three-electrode defibrillation configuration (right-ventricle to case plus superior vena cava).
  • At least one offset time is stored and preferably four (4) in the preferred embodiment.
  • the initial value of offset time ⁇ T is preferably about 0 ms whereby the initial test shock is delivered such that it substantially coincides with the maximum of the derivative of the T-wave following the next pacer spike 90a'.
  • the initial test shock energy is sufficiently strong such that fibrillation is not induced.
  • pacing from the pacing circuit 62 is turned off and the cardiac rhythm is monitored by the sensing and storage circuit 60 for the presence of fibrillation.
  • the controller 56 waits the predetermined wait period before initializing the chain of events that results in a fourth test shock at the first shock strength.
  • Timing circuit 58 determines a time interval 200d from pacing spike 90d corresponding to the base interval 100 plus a fourth ⁇ Td which is preferably plus 40 ms.
  • the resultant shock time point 210d that is preferably 40 ms after the maximum 98d derivative of the T-wave 194d.
  • the cardiac rhythm is monitored by the sensing circuit 60 to ascertain if the shock has induced fibrillation. If fibrillation is not induced, the controller 56 waits the predetermined wait period before delivering the next test shock.
  • controller 56 lowers the shock strength by a predetermined test-shock strength decrement value which is also stored in memory unit 64 and set by a predetermined protocol.
  • the controller 56 waits the predetermined wait period before transmitting the newly determined, second test-shock strength to the test-shock driver 54 and then to shock subsystem 52 after the predetermined waiting period. This initiates a second series of up to four test shocks.
  • the first test shock in the second round is delivered at a first time point corresponding to a first timing interval determined by timing circuit 58 after a pacing spike 90.
  • all of the time offsets ⁇ T in the second round are equivalent to those in the first test shock sequence.
  • one or more of the time offsets may be varied.
  • the amount by which the second test-shock strength is reduced relative to the first shock strength i.e. the shock energy decrement value
  • the preferred decrement value is about 5 J at test-shock strengths of 10 J or greater and about 2 J at test-shock strengths of about 5 J or less.
  • the specific values may be selected from one of various testing strategies, including those used for selecting shock decrement values for DFT testing.
  • the sequence of test shocks in the second sequence is repeated in the same manner as that described with respect to the starting sequence until fibrillation is induced.
  • one or more subsequent rounds of test shocks may be administered until the system minimum level shock strength, typically 2 J - 5 J, is reached.
  • Each subsequent round preferably has the same maximum number of test shocks, each delivered at the same corresponding time offsets ⁇ T relative to the end of time interval 100, which is updated prior to each test shock.
  • the test-shock strength of the next round is determined by lowering the shock strength of the previous round by a decrement value that in general is specific to the shock value corresponding to the previous round.
  • the shock strength of the last shock sequence in which no shock induced fibrillation i.e. the shock strength of the prior shock sequence
  • the shock strength of the last shock sequence in which no shock induced fibrillation may be accepted as the step-down ULV (which is an accurate estimate of the DFT). If fibrillation has not been induced even at the system minimum, 1 - 5 J level as determined in step 85, the ULV is calculated to be the minimum tested shock strength in step 87; and the defibrillation shock strength is set to a level incrementally above the ULV, preferably with an increment of at least 5 J.
  • step 89a determines that fibrillation has been induced at least once.
  • step 89b determines if the present shock is the last shock in a four-shock sequence. If it is, the ULV is set equal to this value in step 87. If the present shock is not the last shock in a four-shock sequence, step 89b continues the testing sequence.
  • a preferred embodiment of the method of the present invention begins with step 72 wherein a first or starting test-shock strength, one or more offset time intervals ( ⁇ T), and one or more test-shock strength decrement value(s) are stored in and retrieved from memory unit 64 of the ULV subsystem 50.
  • the starting shock strength, shock decrement value, and offset times ⁇ T are chosen according to a predetermined protocol.
  • the preferred first shock strength is in the range of 10 -15 J, but may range from 5 J to 30 J.
  • the preferred number of shocks is four (4).
  • each test-shock strength there is a set of up to four test shocks corresponding to each of the four shock time points 210a-d.
  • Each test-shock time 210a-d falls at the end of time intervals 200a-d, after a respective pacing spikes 90a-d'.
  • the time intervals 210a-d , 210b, 210c and 210d are calculated by adding an offset times ⁇ Ta-d to base time intervals 100a-d.
  • the base time 100a-d is the time between the pacing spike 90a-d to the maximum derivative of the T-wave 194a-d in the electrogram 192a-d proceeding electrograms 192a-d.
  • time intervals 200a-d are calculated based on electrogram measurements made in paced rhythm.
  • step 74 initiates overdrive pacing of the heart.
  • One method for selecting intervals in paced rhythm is shown in step 73. This method may be applied only if a recorded electrogram has a suitable monophasic T-wave.
  • step 76 pacing is confirmed and electrograms are recorded.
  • step 73 the peak of the latest peaking monophasic T-wave is identified by analyzing electrogram morphology in each recorded lead. The preferred method for selecting intervals in paced rhythm is shown in steps 71, 75, and 77. This method can be applied regardless of whether a monophasic T-wave is present.
  • step 71 the electrograms recorded and analyzed in step 76 are differentiated with respect to time.
  • step 75 the maximum of the time derivative of the T-wave is determined from the first time derivative of each electrogram 196a, the latest of these peaks 98a is selected, and base time 100a is calculated from the pacer spike 90a to such peak 98a.
  • a shock-time interval 200a is calculated by adding one of a predetermined time offset intervals ⁇ T stored in step 72 to the base interval 100a determined in step 75.
  • ⁇ T may be positive, negative, or zero.
  • Offset time ⁇ T ranges between negative (-) 60 ms and positive (+) 40 ms and is preferably -40 ms to + 20 ms.
  • the initial ⁇ Ta is preferably about 0 ms.
  • first time interval 200a is calculated based on ⁇ Ta of 0 ms. It starts at the time of pacing spike 90a' and ends at shock-time point 210a, which occurs substantially simultaneously with the latest maximum peak of the derivative of the T-wave. As FIG.
  • step 84 resets the counter to one.
  • step 70 determines a new test-shock strength based on adding the predetermined shock decrement value stored in step 72, preferably 5 J, to the existing test-shock strength used in step 70.
  • the second round or sequence of test shocks then delivers shocks in the same manner as that described above with respect to the first sequence. If after the second round of test shocks, fibrillation has not been induced, one or more additional rounds of test shocks are administered provided the system minimum level of shock strength, typically 5 J, has not been reached as determined in step 85.
  • time delays are calculated in a similar fashion, except that they are based on measurements made in normal rhythm or atrial-paced rhythm.
  • a time interval is calculated based on the interval between the detected QRS complex (as opposed to a pacer spike) and the peak of the time derivative of the selected intra-cardiac T-wave.
  • step 76 also includes the sub-step of determining that the heart's rhythm is sufficiently regular that the time interval between the detected QRS complex and the peak of the derivative of the intra-cardiac T-wave is likely to be substantially constant over a few beats.

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EP13180020.3A 2002-04-15 2003-04-09 Defibrillationsschockstärkenbestimmungstechnik Expired - Lifetime EP2664357B1 (de)

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US37240202P 2002-04-15 2002-04-15
US10/351,143 US6675042B2 (en) 2002-04-15 2003-01-27 Defibrillation shock strength determination technology
EP03719679.7A EP1515779B1 (de) 2002-04-15 2003-04-09 Defibrillationsschockstärken-bestimmungstechnik

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US7257441B2 (en) 2007-08-14
US20030195569A1 (en) 2003-10-16
EP1515779A4 (de) 2010-06-09
US20040106955A1 (en) 2004-06-03
US6675042B2 (en) 2004-01-06
EP2664357B1 (de) 2015-04-01
EP1515779A1 (de) 2005-03-23
EP1515779B1 (de) 2013-10-30
WO2003089060A1 (en) 2003-10-30
AU2003223544A1 (en) 2003-11-03

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